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SPECIAL CONTROLS DOCUMENT

Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays Guidance for Industry and FDA Staff January 2007

Final
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance document was developed as a special controls guidance to support the classification of quality control material for cystic fibrosis nucleic acid assays into class II (special controls). A quality control material for cystic fibrosis nucleic acid assays is a device intended to help monitor reliability of a test system by detecting analytical deviations such as those that may arise from reagent or instrument variation in genetic testing. This type of device includes recombinant, synthetic, and cell line-based DNA controls.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.